DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Newly amended claims 1 and 6 and newly submitted claims 31-37 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: claims 1, 6, 31-33, and 35-37 are drawn to the non-elected embodiment of species A1, and claim 34 is drawn to non-elected embodiment of species A3, neither of which are the elected embodiment of species A2.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 1, 6, 31-33, and 35-37 withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Claim Objections
Claim 39 is objected to because of the following informalities:
In line 2, “silicon-like” should be changed to “silicone-like.”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 15, 38, and 39 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 15 recites the first adhesive composition comprising a greater adhesive strength than the second adhesive composition to “discourage edge peeling from the patient skin.” The metes and bounds of the level of edge peeling discouragement cannot be ascertained with certainty. Also, it is unclear under what conditions the discouragement of peeling is too occur, should the adhesiveness be strong enough to withstand someone attempting manual peeling, after water exposure, or for a certain period of time. The purported results of this claimed greater adhesiveness level is indefinite unless a specific amount or degree of adhesiveness is specified in the claim. It is noted that patient skin types and conditions can vary which would also affect the degree of adhesiveness thereto. For examination purposes, the limitation will be interpreted as the first adhesive composition being greater relative to the second adhesive composition and/or any inherent adhesiveness of the prior art is capable of discouraging edge peeling to at least some extent.
Claims 38 and 39 are both dependent on canceled claim 16 and are thereby indefinite. For the purpose of examination, it will be assumed that claims 38 and 39 are dependent on claim 15.
Claim 39 recites a “silicon-like adhesive.” It is unclear if the second adhesive composition is meant to comprise silicon (silicone) or not. Since the scope cannot be ascertained, the term is indefinite. For examination purposes, the inclusion of silicon will be assumed.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 15, 38, and 39 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication No. 2021/0161720 to Kantrowitz et al. (“Kantrowitz”) in view of U.S. Patent Publication No. 2014/0378799 to Chattaraj et al. (“Chattaraj”) and U.S. Patent Publication No. 2022/0062538 to Tomlinson et al. (“Tomlinson”).
Regarding claim 15, Kantrowitz teaches an apparatus comprising a medical device (Fig. 3A) comprising a base portion (200) having a base portion first side and a base portion second side opposite the base portion first side (two opposing sides of 200), an adhesive patch (330, Fig. 6) configured to be placed between the base portion first side and patient skin, wherein the adhesive patch comprises an adhesive patch first side (bottom side of 330) configured to face the patient skin and an adhesive patch second side (top side of 330) facing the base portion first side, wherein the adhesive patch first side comprises an adhesive layer (Figs. 5A-C are examples used to attach the dressing to the skin), and an attachment device (one of Figs. 5A-C used to attach the patch to 200) attaching the base portion first side to the adhesive patch second side, but does not teach the second adhesive layer on a second section and the attachment device being a mechanical fastener.
Chattaraj teaches an attachment device comprising a mechanical fastener (80/90, Fig. 4) as an alternative to an adhesive for attaching a medical device to a body of a patient ([0039] and Figs. 1-4). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted a mechanical fastener for the adhesive as the attachment device in Kantrowitz as taught by Chattaraj since both elements are obvious art-recognized alternative attachment means to obtain the predictable result of providing fastening between a medical device and a body of a user.
Tomlinson teaches an adhesive layer (Fig. 8) comprising a first adhesive composition disposed on a first section (35) and a second adhesive layer disposed on a second section (34), wherein the first adhesive composition comprises a greater adhesive strength than the second adhesive composition ([0143] & [0090]) to discourage edge peeling from the patient skin (the adhesive of Tomlinson is capable of discouraging edge peeling, see 112 rejection above for interpretation). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to yield the predictable result of providing adhesiveness in varying degrees to suit the particular need or optimize a particular application.
Regarding claim 38, Kantrowitz, Chattaraj, and Tomlinson teach the apparatus of claim 15
Regarding claim 39, Kantrowitz, Chattaraj, and Tomlinson teach the apparatus of claim 15
Response to Arguments
Applicant’s arguments and amendments with respect to drawing objections have been fully considered and are persuasive. The drawing objections been withdrawn.
Applicant’s arguments and amendments with respect to 112 rejections have been fully considered and are persuasive. The 112 rejections been withdrawn. However new 112 rejections have been issued in response to Applicant’s amendments.
Applicant’s arguments and amendments with respect to the art rejections have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Kantrowitz, Chattaraj, and Tomlinson as shown above in response to Applicant’s amendments.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/B.K./Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783